Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer

European Lung Cancer Working Party

Status: Completed

Conditions: Non Small Cell Lung Carcinoma

Treatments: Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00864266

01082

Details and patient eligibility

About

The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of non-small-cell lung cancer (NSCLC)
• Obtention of a biopsy of the tumour according to the procedure defined in the protocol
• NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
• Presence of at least one assessable lesion
• Availability for participating in the detailed follow-up of the protocol
• Signed informed consent.
• Age above 18 years

Exclusion criteria

• Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
• NSCLC treated by exclusive surgery or radiotherapy
• A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

1

Experimental group

Description:

After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)

Treatment:

Drug: Chemotherapy